510(k) Report

Devices descending from K061094

2 later devices reach Newport E500 Wave Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+2K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—